1. Field of the Invention
The present invention relates generally to a medical device utilized in endotracheal intubation, and more particularly, to an endotracheal tube placement system and method, including a placement-assistive handle, an oral anchor, mechanized advancer, and an integrated video viewing system allowing simultaneous visualization of the airway without a direct line of sight and introduction of the endotracheal tube.
2. Description of the Prior Art
Successful management of a patient's airway is vital. The clinician must combine quick, accurate decisions and proficient procedural skills with the proper equipment to achieve this goal. Often intubation with an endotracheal tube is required.
Standard intubation uses the direct laryngoscopy technique with a blade, such as a curved Macintosh blade. After positioning the patient's head and upper body to align the oral, pharyngeal, and laryngeal axes, the handle of the blade is held in the left hand, with the right hand used to open the mouth. The blade is inserted to the right of the tongue. When the blade approaches the base of the tongue, some traction is exerted along the long axis of the laryngoscope handle to compress the tongue, improving the ability to see the epiglottis. The tip of the blade is advanced, centered, and seated in the vallecula (the space at the junction of the base of the tongue and the origin of the epiglottis) with additional lift applied along the longitudinal axis of the laryngoscope handle to further compress the tongue and to help lift the epiglottis to reveal the vocal cords beneath.
Standard direct laryngoscopy presents a variety of problems. Care must be taken not to damage the patient's upper teeth with the laryngoscope, while attempting to attain a better view. Cervical spine injury, poor neck mobility, limited jaw opening, prominent upper teeth, and other anatomic or pathologic conditions may make standard direct laryngoscopy difficult. The manipulation of the airway increases airway trauma, as does one or more failed intubation attempts to access the trachea. Advantageously, the endotracheal tube placement system of the present invention requires less manipulation, of the airway. The decrease in manipulation reduces airway trauma, edema, and secretions, resulting in a faster recovery and extubation. Further, the endotracheal tube placement system of the present invention provides protection for the patient's teeth and saves time by eliminating the time needed to align the oral, pharyngeal, and laryngeal axes.
Direct laryngoscopy has a considerable learning curve, with studies showing best results are achieved after about 50 direct laryngoscope procedures are completed. Due to the difficulty in performing the procedure without considerable practice, laryngoscopy is generally limited to experienced laryngoscopists or anesthesiologists. Advantageously, the ease of use of the endotracheal tube placement system of the present invention allows any medical professional to intubate a patient when needed.
Although alternative intubation devices are available that may permit easier tracheal intubation in some patients who present significant difficulty with direct laryngoscopy, the endotracheal tube placement system of the present invention provides significant advantages over currently available alternative intubation devices, also.
In many of these currently available alternative intubation procedures the device is inserted, carefully advanced past the oropharynx, epiglottis, and vocal cords into the trachea, and then the endotracheal tube is introduced, with the device then removed. Advantageously, the endotracheal tube placement system of the present invention saves time in establishing an airway, as the endotracheal tube is introduced simultaneously as the airway is visualized.
Other alternative intubation procedures do not allow visualization of the intubation area. For example, a lightwand, such as the Trachlight, is a flexible wand with a distal light and retractable internal wire stylet that attaches to a handle with the correct placement of the end of the endotracheal tube confirmed by soft tissue transillumination in the neck, with the clinician seeing a circumscribed glow at the neck front from the distal light. The lightwand is a blind technique, and lacks the ease of use and visualization of the intubation area provided by the present invention.
When direct visualization of the vocal cords is limited or unattainable during standard direct laryngoscopy, some other alternative intubation devices and procedures allow indirect visualization of, the vocal cords, such as, for example, flexible fiberoptic laryngoscopy and video laryngoscopy.
A fiberoptic scope has a proximal eyepiece and a semi-malleable stylet carrying an endotracheal tube. The fiberoptic scope is inserted over or beside the tongue and advanced past the epiglottis and through the vocal cords. The endotracheal tube can then be further advanced off the stylet down the trachea. While the endotracheal tube is introduced while indirectly viewing the laryngeal area, the manipulation of the fiberoptic scope during placement is not easy or intuitive. Additionally, some fiberoptic scopes do not have integrated suction, so blood and secretions will make use of the fiberoptic scope difficult. The endotracheal tube placement system of the present invention provides an integrated suction option and allows intuitive, straightforward movements of the wrist of the clinician to manipulate and to position the endotracheal tube carried by the manipulator.
Indirect visualization of the vocal cords can also be obtained by using a video laryngoscope. Video laryngoscopy uses video technology with a camera located near the distal end of a rigid blade and a display device, such as a video monitor, to display the view at the distal end of the blade.
Video laryngoscopes are conventionally available in two varieties, one in which an adapter is used to attach a video camera to the eyepiece of a conventional fiberoptic device, and another in which the video technology is integrated into the laryngoscope, such as the video laryngoscope sold under the trademark Glidescope. The integrated video laryngoscope generally is composed of a plastic, one-piece blade and handle, with a miniature video camera and light-emitting diode (LED) light source toward its distal end. A cable, allowing transmission of the image obtained, connects the video camera to a liquid-crystal display (LCD) color monitor. Once the laryngeal inlet has been visualized, the clinician guides a stylet carrying an endotracheal tube toward and through the vocal cords. While the video laryngoscope is useful in difficult intubations to view the larynx, the procedure learning curve is challenging. Further, the additional step of guiding the styletted endotracheal tube toward and through the vocal cords, after positioning the video laryngoscope, increases the time required for the vital procedure, delaying oxygenation. Advantageously, the endotracheal tube placement system of the present invention allows simultaneous indirect visualization of the airway and introduction of an endotracheal tube, saving valuable time during an emergency in which securing an airway is the beginning step in resuscitation.
Further, some conventional fiberoptic scopes and video assisted laryngoscopes are bulky and/or complicated. The handheld endotracheal tube placement system of the present invention is self-contained, battery operated, and portable; therefore, the endotracheal tube placement system of the present invention is available in any situation. Easy disassembly of parts allows for easy storage into a portable carrying case, thus enhancing convenience, especially for transport and use by emergency personnel and for storage.
Additionally, with the conventionally available endotracheal tube placement systems, the guidance and manipulation of the endotracheal tube tip is difficult. The endotracheal tube placement system of the present invention provides a placement-assistive handle facilitating easy manipulation of the endotracheal tube tip toward any direction: Using simple, intuitive wrist movement, the endotracheal tube tip will move where desired. This gives greater control and precision, ultimately saving valuable time.
Accordingly, there is an established need for a convenient, compact, self-contained endotracheal tube placement system that has a less challenging learning curve; that allows a clinician to simultaneously indirectly view the laryngeal area as the endotracheal tube is being properly placed in position; that allows the tip of the endotracheal tube to be easily guided and manipulated with a simple wrist movement; and that minimizes airway trauma through decreased manipulation of the airway, resulting in a faster recovery and extubation.